Onco gets FDA nod for chemotherapy drug

Onco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab Ltd, has announced that it has received US FDA approval for its Doxorubicin Hydrochloride injection. Doxorubicin is a cancer chemotherapy drug, used in the treatment of a wide range of cancers, including haematological malignancies, many types of carcinoma, and soft tissue sarcomas. The drug is administered intravenously, in the form of hydrochloride salt. The company in a statement to the exchanges said Doxorubicin is amongst the products in the drug shortage list of US FDA and is part of the oncology portfolio licensed to Pfizer in January 2010. For the US market, the company plans launch shortly in 10 mg/ vial and 50 mg/ vial. According to IMS data in June, the US market for generic Doxorubicin (liquid and lyophilised) is valued around $16.8 million.